Identity
- Trade Name
- Prodigy AutoCode Blood Glucose Monitoring System FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Prodigy AutoCode Blood Glucose Monitoring System (KIT) FDA UDI
- Model / Reference
- 051890 FDA UDI
- Description
- Prodigy AutoCode Blood Glucose Monitoring System (KIT) FDA UDI
Identifiers
- Catalog Number
- 051890 FDA UDI
- Primary DI / UDI-DI
- 00384840518902 FDA UDI
- 510(k) Number
- K073118 FDA UDI
- FDA Product Code
- JJT FDA UDIFMI FDA UDIJJX FDA UDICGA FDA UDINBW FDA UDI
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI880.5570 FDA UDI862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, kit, electrometryManual blood lancing device, reusableGlucose IVD, controlHome-use/point-of-care blood glucose monitoring system IVD
Prodigy AutoCode Blood Glucose Monitoring System by Prodigy Diabetes Care, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prodigy Diabetes Care, Llc
Sources (1)
- FDA UDI f162915c-1c98-462f-8a1f-c870e1b3c976 36 fields · synced May 30, 2026